Because I practice pharmaceutical injury law nationwide, I’ve been very interested in the debate over “innovator liability” in Alabama. That’s the name for the legal theory the Alabama Supreme Court has come up with in order to hold name-brand drug manufacturers legally liable for injuries caused by the generic equivalents to their drugs. The U.S. Supreme Court has ruled that generic manufacturers cannot be held responsible for failure to warn patients about their drugs’ risks because any such decision would contradict federal regulations requiring them to have the exact same labels as the name-brand equivalent drug. The Alabama court reasoned that this makes name-brand manufacturers, who do have control over their labels, liable for failure to warn even when the drug that injured the plaintiff was a generic. That decision is being reconsidered this week by the high court, and observers on both sides are watching closely.
The case under consideration is Wyeth v. Weeks, in which Danny Weeks and his wife, Vicki Weeks, sued both generic and name-brand manufacturers for failure to warn about problems with the drug Reglan (metoclopramide). Danny Weeks took generic Reglan and eventually developed tardive dyskinesia, an irreversible nervous-system problem in which the patient has uncontrollable head or facial movements. The Weekses conceded that Danny never used name-brand Reglan. A federal district court concluded that they might have a case and certified a question of Alabama law to the state Supreme Court. That court surprised observers by ruling that people like Weeks may have a case against a name-brand manufacturer if it made statements that materially misinformed their doctors. It said U.S. Supreme Court precedent makes manufacturers responsible for labels on generics, making it reasonably foreseeable that their safety communications might lead to liability.
The Alabama court is in the minority of courts that have considered this issue. Most courts (with exceptions in California and Vermont) have concluded that the tort laws of various states require them to dismiss claims against any manufacturer whose drugs the defendant didn’t actually use. As a result of that—and a loud outcry from the pharmaceutical industry and other business interests—the Alabama high court took the unusual step of agreeing to rehear its decisions. Oral arguments on that were scheduled for Sept. 4. A dissenting justice in the original Alabama case pointed out that there was no good decision for the court; U.S. Supreme Court precedent essentially denies any relief to people like Weeks. The FDA is reportedly addressing the issue through its rulemaking process, but that process is glacial and may be interrupted by a change in presidents.
I applauded the Weeks case at the time it came out, and I still do. When you’re a lawyer representing people hurt by dangerous drugs, you start to see how much we all rely on pharmaceutical companies and doctors to provide us with good information. When drug companies knowingly withhold important safety information, as alleged in this case, patients and doctors who trust those companies are put at risk. And that risk is not small; tardive dyskinesia is a permanent disability. In other high-profile defective drug litigation, the states can be a woman’s ability to have children—as in the Mirena IUD lawsuits—or even death, as in the series of Vioxx cases. Even opponents of “innovator liability” agree that the situation is unfair.
If you suffered a serious injury or lost a family member because of a dangerous medication, don’t wait to call Carey, Danis & Lowe for a free consultation on your rights and your options. You can reach us through our website or call 1-877-678-3400 today.
Similar blog posts:
Brand Name Drug Makers May Be Held Liable in Alabama for Injury From Generic Drugs – Wyeth et al v. Weeks
Drug Manufacturers Ask Alabama Court to Reconsider Allowing Lawsuits Over Generics
Alabama Supreme Court May Allow Generic Reglan Lawsuits